Virologic responses to a ritonavir--saquinavir-containing regimen in patients who had previously failed nelfinavir.

Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

Virologic responses to a ritonavir--saquinavir-containing regimen in patients who had previously failed nelfinavir.

AIDS. 1999 Feb 4;13(2):F23-8. Unique Identifier : AIDSLINE MED/99217470
Tebas P; Patick AK; Kane EM; Klebert MK; Simpson JH; Erice A; Powderly WG; Henry K; Department of Medicine Washington University, St Louis, Missouri; 63108, USA.

Abstract: OBJECTIVES: The effectiveness of a second protease inhibitor in patients who failed an initial protease inhibitor is unclear but believed to be low. It has been postulated, however, that patients who fail nelfinavir may respond differently. We therefore assessed the virologic response to a ritonavir-saquinavir-containing regimen in patients who had previously failed nelfinavir. METHODS: A total of 26 patients enrolled in the nelfinavir clinical trials AG506 and AG511 at our two sites who failed (two consecutive HIV viral loads > 5000 copies/ml; branched DNA assay) were switched to a combination of stavudine 40 mg twice daily, lamivudine 150 mg twice daily, ritonavir 400 mg twice daily and saquinavir 400 mg twice daily. RESULTS: The mean viral load at enrollment in this study was 46 674 copies/ml (range, 1075-146400 copies/ml). The median CD4 cell count was 222 x 10(6)/l (range, 82-448 x 10(6)/l). The median duration of nelfinavir use with a detectable viral load before the switch occurred was 48 weeks. Two patients discontinued the study at 3 weeks. All of the remaining patients (n = 24) reached undetectable viral loads (< 500 copies/ml) that were sustained at week 24 in 17 (71%) out of 24 subjects. The most frequent baseline mutations in the protease gene prior to switching were D30N (13 out of 18), N88D (eight out of 18) and M36I (eight out of 18). The presence or absence of these mutations was not predictive of a short-term virologic response. CONCLUSIONS: Most patients who failed a nelfinavir-containing regimen responded to a switch to a combination regimen with saquinavir-ritonavir.

Keywords: CLINICAL TRIAL JOURNAL ARTICLE Anti-HIV Agents/*THERAPEUTIC USE CD4 Lymphocyte Count Drug Therapy, Combination Human HIV Infections/*DRUG THERAPY/IMMUNOLOGY/*VIROLOGY HIV Protease/GENETICS HIV Protease Inhibitors/*THERAPEUTIC USE *HIV-1/GENETICS Nelfinavir/*THERAPEUTIC USE Predictive Value of Tests Prospective Studies Ritonavir/*THERAPEUTIC USE RNA, Viral Saquinavir/*THERAPEUTIC USE Support, Non-U.S. Gov't Treatment Failure *Viral Load
990830
A9981019

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